Medicines recallMHRA
Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution recalled over a labelling error
Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market. The incorrectly labelled ampoules are the same product and contain the same active ingredient but have Korean language labels and different batch details.
Check your product
Only products that match these details are covered. Have your pack in front of you.
3 identifiers listed for this notice.
Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution 20 ampoules
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- UK25B06
- ExpiryOn the carton, blister or label.
- 31/03/2028
- First distributedOn the product, its label or its packaging.
- 04/07/2025
What to do now
A printing or labelling mistake affects some packs of Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/45). Quoted as issued.
Summary
Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market. The incorrectly labelled ampoules are the same product and contain the same active ingredient but have Korean language labels and different batch details.
The risk
DMRC reference number DMRC - 37371169 Marketing Authorisation Holder
Advice for healthcare professionals
Stop supplying the above batch immediately.
Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
No action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level.
Patients who have taken the mislabelled ampoules will have received the correct medication as it is the same product but with labels intended for the Korean market.
If you have concerns about this, contact your dispensing pharmacist in the first instance.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
No action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level.
Patients who have taken the mislabelled ampoules will have received the correct medication as it is the same product but with labels intended for the Korean market.
If you have concerns about this, contact your dispensing pharmacist in the first instance.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution been recalled?
A printing or labelling mistake affects some packs of Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.